MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
A Randomized, Open-Label, Phase 2a Comparator Study to Assess the Pharmacodynamics, Safety and Pharmacokinetics of Oral Administration MNK6106 (L-Ornithine Phenylacetate) Versus Rifaximin in Subjects With Hepatic Cirrhosis and a History of Prior Episodes of Hepatic Encephalopathy
1 other identifier
interventional
50
2 countries
5
Brief Summary
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use. Participants will be adults with liver disease that has affected the brain in the past.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2018
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2020
CompletedResults Posted
Study results publicly available
July 20, 2021
CompletedJuly 20, 2021
June 1, 2021
1.6 years
October 16, 2018
June 29, 2021
June 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Ammonia Plasma Levels at Baseline and Day 5
This test measures the level of ammonia in your blood. Ammonia, also known as NH3, is a waste product made by your body during the digestion of protein. Normally, ammonia is processed in the liver, where it is changed into another waste product called urea. Urea is passed from the body in urine. If your body cannot process or eliminate ammonia, a lab test of a blood sample shows it has built up in the bloodstream. High ammonia levels in the blood can lead to serious health problems, including hepatic encephalopathy.
Baseline, Day 5
Secondary Outcomes (1)
Number of Participants With Adverse Events by the End of the Trial
within 15 days
Study Arms (4)
Group A: MNK6106 2 grams (tid)
EXPERIMENTALParticipants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
Group B: MNK6106 4 grams (bid)
EXPERIMENTALParticipants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
Group C: MNK6106 4 grams (tid)
EXPERIMENTALParticipants receive 4 tablets of MNK6106 tid for 5 days
Group D: Rifaximin 550 mg (bid)
ACTIVE COMPARATORParticipants receive 1 tablet of rifaximin bid for 5 days
Interventions
1 gram tablet of MNK6106 for oral administration
550 mg tablet of rifaximin for oral administration
Eligibility Criteria
You may qualify if:
- A potential participant may only be included if (at screening), he/she:
- Understands the study and has signed informed consent
- Is an adult, not pregnant or lactating
- Has cirrhosis of the liver
- Has had 1 instance of HE within 12 months
- Has hyperammonaemia defined as ≥37 μmol/L at screening
You may not qualify if:
- A potential participant will be excluded if (at screening), he/she:
- Has contraindicated allergies
- Expects liver transplant within 1 month
- Has had a liver shunt within the last 3 months
- Has inadequate kidney, gastrointestinal, or cardiac function
- Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:
- the safety and well-being of the participant or potential offspring
- the safety of study staff
- the analysis of results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (5)
Southern California Research Center
Coronado, California, 92118, United States
Inland Empire Clinical Trials
Rialto, California, 92377, United States
Global Clinical Professionals
St. Petersburg, Florida, 33702, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215, United States
Fundacion de Investigacion (Research Foundation)
San Juan, 00927, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2018
First Posted
October 19, 2018
Study Start
December 1, 2018
Primary Completion
July 14, 2020
Study Completion
July 14, 2020
Last Updated
July 20, 2021
Results First Posted
July 20, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03712280) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.